Quality Engineer

Job Description

Job Description

Description :

Celularity Inc., headquartered in Florham Park, N.J ., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases.

Celularity is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor ("CAR"), natural killer ("NK") cells, and mesenchymal-like adherent stromal cells ("MLASCs") and exosomes.

These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.

We are seeking a detail-oriented and experienced Quality Engineer to join our biotechnology team. The Quality Engineer will play a crucial role in ensuring compliance with FDA regulations and maintaining high standards of quality throughout our product development and manufacturing processes, specifically focusing on QA review of calibration, equipment qualification, process qualification, and preventative maintenance.

The ideal candidate will have a strong background in quality assurance within FDA-regulated environments, particularly in biotechnology or pharmaceutical industries.

This role provides Quality oversight of Tissue Products (351 / 361) and Cell Therapy Products.

Requirements :

Duties and Responsibilities

• Develop and implement quality assurance processes and procedures in compliance with FDA regulations, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), with a specific focus on calibration, equipment qualification, process qualification, and preventative maintenance.
• Review calibration, qualification and maintenance documents for compliance with regulations, standards and procedures.
• Conduct risk assessments and develop risk management strategies to mitigate potential quality issues related to calibration, equipment, and process qualifications.
• Investigate non-conformances, deviations, and customer complaints related to calibration, equipment qualification, and process qualification, and implement corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams to resolve quality-related issues specific to calibration, equipment qualification, process qualification, and preventative maintenance, ensuring effective implementation of quality improvements.
• Review and approve procedures, protocols and reports, focused on calibration, equipment qualification, process validation, and cleaning validation protocols.
• Provide guidance and training to staff on quality standards, procedures, and regulatory requirements pertaining to calibration, equipment qualification, process qualification, and preventative maintenance.
• Stay current with industry trends, regulatory requirements, and best practices in Quality Assurance, particularly as they relate to calibration, equipment qualification, process qualification, and preventative maintenance.

Education and Experience

• Bachelor’s degree in Bioengineering, Biology, or related field. Advanced Degree preferred.
• Minimum of 3 years of experience as a Quality Engineer (5 years for Senior Quality Engineer) or in a similar role within FDA-regulated industries, preferably biotechnology or pharmaceuticals.
• In-depth knowledge of FDA regulations, CGMP, GLP, and other relevant quality standards, particularly as they pertain to calibration, equipment qualification, process qualification, and preventative maintenance.
• Experience with quality management systems (e.g., ISO 13485, 21 CFR Part 820) related to calibration, equipment qualification, process qualification, and preventative maintenance.
• Strong analytical and problem-solving skills, with a focus on technical aspects of calibration, equipment qualification, process qualification, and preventative maintenance.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment focused on calibration, equipment qualification, process qualification, and preventative maintenance.
• Detail-oriented with strong organizational skills and the ability to manage multiple priorities, specifically in the context of calibration, equipment qualification, process qualification, and preventative maintenance.
• Strong knowledge of ICH Q9 Quality Risk Management as it applies to phase-appropriate, particularly related to calibration, equipment qualification, process qualification, and preventative maintenance.

Working Conditions

• The incumbent will be working in an office environment but will often visit and engage with manufacturing personnel in the laboratories.
• Flexible scheduling required.
• Some light lifting may be required occasionally.
• Must be able to gown aseptically.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

There are other duties and responsibilities considered incidental or secondary to this job's overall purpose. Employees / contractors holding this position will be required to perform any other job-related duties as requested by management.

Must be authorized to work directly for Celularity in the U.S.

No agency submittals accepted

Celularity is an Equal Opportunity Employer